Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM

Completed · Not applicable

Conditions studied: Traumatic Amputation of Arm

In brief

The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater skeletal stabilization. The investigators comparisons included assessments of patient comfort and satisfaction with fit, as well as dynamic kinematic assessment using X-Ray Reconstruction of Moving Morphology (XROMM) a novel high-speed, high-resolution, bi-plane video radiography system.

Key facts

Study ID

NCT01546675

Run by

US Department of Veterans Affairs

People needed

2

Starts

2012-01-01

Expected to finish

2013-09-01

Last updated by the study team

2014-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female transhumeral amputees, 18 years or older of any ethnicity, who are current prosthetic users.

You may not qualify if…

• Subjects with frozen shoulder of the residual side, and/or severely limited active range of motion of the shoulder joint of the residual limb
• Inability to tolerate wearing of a prosthetic socket
• Mental impairment that renders a subject unable to comply with the study
• Skin conditions such as burns or poor skin coverage as well as those with severe contractures that prevent prior prosthetic wear
• Any electrically controlled medical device including pacemaker, implanted defibrillator or drug pumps
• Neuropathy, uncontrolled diabetes, receiving dialysis
• Any other significant comorbidity which would interfere with the study
• Severe circulatory problems including peripheral vascular disease and pitting edema will be excluded
• Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
• Women who are pregnant or who plan to become pregnant in the near future

Where it is running

• Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY — New York, New York, United States
• Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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